BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE

    MDR report key: 6751035 · Received July 28, 2017

    Report

    Report Number
    1911916-2017-00073
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    February 8, 2017
    Report Date
    July 20, 2017
    Manufacturer
    BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: NO SAMPLES WERE RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 5240603. CONCLUSIONS: WITHOUT A SAMPLE, THE REPORTED PROBLEM COULD NOT BE CONFIRMED AND A ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER WAS UNABLE TO WITHDRAW THE EYLEA FROM THE VIAL INTO THE SYRINGE USING THE 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE ON TWO OCCASIONS. IT WAS BELIEVED THAT IT WAS AN ISSUE WITH THE FILTER NEEDLE AS IT APPEARED AS THOUGH THERE WERE PARTICLES IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530585 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE FILTER NEEDLE GAA BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS 5240603

    Patients

    Seq Age Sex Outcome Treatment
    1 Other